Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU) SF 424 (R&R) Other Project Information – Project Summary The Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU), current NIAID CRMS site 60338, is a collaboration between the Chiang Mai University-Research Institute for Health Sciences (CMU- RIHES) in Chiang Mai, Thailand, and the Thai Red Cross AIDS Research Centre (TRC-ARC) in Bangkok, Thailand. The specific aims of this application are 1) to renew the THAI CTU as a Clinical Trials Unit to provide scientific, administrative expertise, and infrastructure to conduct clinical studies developed by the four NIH HIV/AIDS Clinical Trials Networks: HIV/AIDS Adult Therapeutics, HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics, HIV Prevention, and HIV Vaccines; and 2) to participate in the development of clinical trials and provide four Clinical Research Sites (CRS) to conduct clinical trials proposed by the four Networks. This CTU renewal involves a change of THAI CTU Principal Investigators from "Suwat Chariyalertsak and Kiat Ruxrungtham" to “Khuanchai Supparatpinyo and Kiat Ruxrungtham". The THAI CTU and its four CRSs will contribute scientifically to the Networks and recruit HIV+ and HIV- participants to clinical studies according to HIV/AIDS research priorities: 1) HIV/AIDS adult therapeutics: 1) interventions to reduce HIV reservoirs; 2) novel and durable interventions targeting HIV treatment; 3) treatment and prevention of drug-sensitive and drug-resistant tuberculosis; 4) treatment and prevention of HIV-related, non-infectious co-morbidities; and 5) studied strategies to cure hepatitis B virus infection in people with and without HIV. High national incidence of viral hepatitis and endemicity of carriage facilitates research on HBV and HCV infections, particularly for cure of hepatitis B. 2) HIV/AIDS maternal, adolescent and pediatric therapeutics: 1) optimization of antiretroviral treatment for these populations; 2) interventions for ART-free remission; 3) treatment and prevention of tuberculosis; 4) treatment and prevention of HIV-related co-morbidities; and 5) treatment and prevention of co-infections. 3) HIV prevention: 1) evaluation of long-acting antiretroviral agents and delivery systems for pre- exposure prophylaxis; 2) evaluation of multipurpose prevention technologies for HIV, pregnancy, sexually transmitted infections, and opioid dependence; 3) evaluation of broadly neutralizing antibodies for pre-exposure prophylaxis; and 4) integrated strategies for HIV prevention. 4) HIV vaccines: 1) evaluation of passive immunization to reduce HIV acquisition in adults; 2) investigation of vaccination of infants; 3) evaluation of immunological, microbiological, and diagnostic technologies for TB vaccination; and 4) research on epidemiological, behavioral, and social sciences for optimization of outcomes of HIV vaccination.

Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU) SF 424 (R&R) Other Project Information – Project Narrative The Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU) is a collaboration between the Chiang Mai University-Research Institute for Health Sciences (CMU-RIHES) in Chiang Mai, Thailand, and the Thai Red Cross AIDS Research Centre (TRC-ARC) in Bangkok, Thailand. The renewed THAI CTU and its four CRSs will participate in developing and conducting clinical trials proposed by the four NIH HIV/AIDS Clinical Trials Networks: HIV/AIDS adult therapeutics; HIV/AIDS maternal, adolescent and pediatric therapeutics; HIV prevention; and HIV vaccines. The collaboration between the NIH HIV/AIDS Clinical Trials Networks and their affiliated CTUs, including the THAI CTU, will lead to development of innovative and effective measures for HIV treatment and prevention, and ultimately to HIV cure and an end to the global HIV epidemic.